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RSS FeedPosted by Michael Wonder on 30 May 2019
Mesoblast initiates rolling submission of biologics license application to U.S. FDA for remestemcel-L in the treatment of acute graft versus host disease
30 May 2019 - Mesoblast today announced that it has filed the first component of a rolling submission for a biologics ...
Posted by Michael Wonder on 30 May 2019
Fibrocell receives FDA regenerative medicine advanced therapy designation for FCX-007 gene therapy for the treatment of RDEB
29 May 2019 - Fibrocell Science today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 30 May 2019
Bayer receives U.S. FDA breakthrough therapy designation for copanlisib for the treatment of marginal zone lymphoma
29 May 2019 - Breakthrough therapy designation for copanlisib primarily based on follow-up data from the pivotal Phase II study ...
Posted by Michael Wonder on 30 May 2019
Zymeworks' lead asset, ZW25, granted fast track designation from the FDA
29 May 2019 - Zymeworks today announced that the U.S. FDA has granted fast track designation to ZW25, a novel azymetric ...
Posted by Michael Wonder on 30 May 2019
Arvinas receives fast track designation for its targeted protein degrader ARV-110 as a treatment for men with metastatic castration-resistant prostate cancer
29 May 2019 - Arvinas today announced that its lead Protac protein degrader, ARV-110, has been granted fast track designation by ...
Posted by Michael Wonder on 30 May 2019
Imara announces FDA fast track designation for IMR-687 for the treatment of sickle cell disease
29 May 2019 - Imara today announced that the U.S. FDA has granted fast track designation to IMR-687, the company’s ...
Posted by Michael Wonder on 29 May 2019
FDA officials call for patient-friendly terminology in oncology
29 May 2019 - Officials from the US FDA's oncology offices say they plan to develop a glossary of patient-friendly ...
Posted by Michael Wonder on 29 May 2019
Health advocate says FDA must walk a 'fine line' to ensure affordable drugs are safe
29 May 2019 - Public health advocate Dinesh Thakur said in an interview that aired Wednesday that the FDA is ...
Posted by Michael Wonder on 29 May 2019
U.S. FDA grants priority review for Vascepa (icosapent ethyl) supplemental new drug application seeking cardiovascular risk reduction indication
29 May 2019 - PDUFA date assigned is 28 September 2019, four months sooner than expected. ...
Posted by Michael Wonder on 29 May 2019
FDA approves Revlimid (lenalidomide) in combination with rituximab for the treatment of adult patients with previously treated follicular lymphoma or marginal zone lymphoma
28 May 2019 - Approval marks the first chemotherapy-free combination regimen for patients who have relapsed or did not respond to ...
Posted by Michael Wonder on 29 May 2019
Sermonix receives FDA fast track designation for investigational drug lasofoxifene
28 May 2019 - Designation allows for expedited development and review of lasofoxifene as a potential precision medicine treatment for women ...
Posted by Michael Wonder on 28 May 2019
Assessment of the clinical benefit of cancer drugs receiving accelerated approval
28 May 2019 - When a cancer drug that has received accelerated approval from the US FDA is claimed to have ...
Posted by Michael Wonder on 28 May 2019
Allergan and Gedeon Richter receive U.S. FDA approval for expanded use of Vraylar (cariprazine) in the treatment of bipolar depression
28 May 2019 - New indication makes Vraylar first and only dopamine and serotonin partial agonist to treat the full spectrum ...
Posted by Michael Wonder on 25 May 2019
RegenxBio announces first FDA approval of a gene therapy based on its proprietary NAV technology platform
24 May 2019 - FDA approval of Novartis' Zolgensma for the treatment of paediatric patients with SMA marks the first regulatory ...
Posted by Michael Wonder on 24 May 2019
FDA approves Jakafi (ruxolitinib) for the treatment of patients with acute graft-versus-host disease
24 May 2019 - Jakafi is the first and only FDA approved treatment for patientswith steroid-refractory acute graft-versus-host disease. ...